Based on the tests, 71.4% of the patients had positive pH studies and 10.4% reported no signs or symptoms of LPR, indicating occult disease. Patients who tested positive for LPR were enrolled in Phase II and treated with esomeprazole magnesium, 40 mg QD, for two months. After two months, the PSG, pH study, QOL survey and subject data collection were repeated.
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October 2007During the study, we did not use CPAP and BiPAP, even though they are a fairly simple and effective treatment for OSA, because the purpose of this study was to evaluate whether the elimination of LPR, as an isolated treatment, could improve OSA, said Dr. Friedman.
In the 32 patients participating in Phase II, snoring levels decreased from 8.7 ± 2.1 to 6.9 ± 2.6 (p09), daytime sleepiness decreased from 14.4 ± 3.5 to 11.2 ± 2.5 (p21), AHI from 33.5 ± 21.6 to 30.1 ± 12.3 (p12), and minimum O2 saturation increased form 85.7 ± 8.3 to 87.1 ± 5.0 (p16).
Although no patients were cured by proton-pump inhibitor therapy alone, the study identified the following important points. First, LPR and OSA are common comorbid conditions; the incidence of LPR in patients with OSA in this study was 71.4%. Second, treatment of LPR had a significant impact on the reduction of AHI, snoring, and daytime sleepiness, and it also improved minimum oxygen saturation.
This was the first study to focus on patients with negative upper esophageal monitoring indicating the elimination of LPR. In patients with both conditions, adequate treatment of LPR with esomeprazole was effective in reducing the subjective and objective findings of OSA and is an important adjunct in the overall management of OSA.
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©2007 The Triological Society
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